Michael Walsh1, Richard Whitlock2, Amit X Garg2, Jean-François Légaré2, Andra E Duncan2, Robert Zimmerman2, Scott Miller2, Stephen Fremes2, Teresa Kieser2, Ganesan Karthikeyan2, Matthew Chan2, Anthony Ho2, Vivian Nasr2, Jessica Vincent2, Imtiaz Ali2, Ronit Lavi2, Daniel I Sessler2, Robert Kramer2, Jeff Gardner2, Summer Syed2, Tomas VanHelder2, Gordon Guyatt2, Purnima Rao-Melacini2, Lehana Thabane2, P J Devereaux2. 1. Population Health Research Institute (Walsh, Whitlock, Vincent, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; McMaster University (Walsh, Whitlock, Syed, VanHelder, Guyatt, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; London Health Sciences Centre (Garg, Lavi), Western University, London, Ont.; Dalhousie University (Légaré), Halifax, NS; Cleveland Clinic (Duncan, Nasr, Sessler), Cleveland, Ohio; Maine Medical Center (Zimmerman, Kramer), Portland, Me.; Wake Forest University (Miller, Gardner), Winston-Salem, NC; Sunnybrook Health Sciences Centre (Fremes), University of Toronto, Toronto, Ont.; University of Calgary (Kieser, Ali), Calgary, Alta.; All India Institute of Medical Sciences (Karthikeyan), New Delhi, India; The Chinese University of Hong Kong (Chan, Ho), Hong Kong SAR, China lastwalsh1975@gmail.com. 2. Population Health Research Institute (Walsh, Whitlock, Vincent, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; McMaster University (Walsh, Whitlock, Syed, VanHelder, Guyatt, Rao-Melacini, Thabane, Devereaux), Hamilton, Ont.; London Health Sciences Centre (Garg, Lavi), Western University, London, Ont.; Dalhousie University (Légaré), Halifax, NS; Cleveland Clinic (Duncan, Nasr, Sessler), Cleveland, Ohio; Maine Medical Center (Zimmerman, Kramer), Portland, Me.; Wake Forest University (Miller, Gardner), Winston-Salem, NC; Sunnybrook Health Sciences Centre (Fremes), University of Toronto, Toronto, Ont.; University of Calgary (Kieser, Ali), Calgary, Alta.; All India Institute of Medical Sciences (Karthikeyan), New Delhi, India; The Chinese University of Hong Kong (Chan, Ho), Hong Kong SAR, China.
Abstract
BACKGROUND:Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery. METHODS:Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase-myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization. RESULTS: We randomly assigned 128 patients toremote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31). INTERPRETATION: Remote ischemic precnditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01071265.
RCT Entities:
BACKGROUND: Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery. METHODS:Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase-myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization. RESULTS: We randomly assigned 128 patients to remote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31). INTERPRETATION: Remote ischemic precnditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01071265.
Authors: Robert F Zimmerman; Prosperity U Ezeanuna; Jane C Kane; Catherine D Cleland; Thejaswini J Kempananjappa; F Lee Lucas; Robert S Kramer Journal: Kidney Int Date: 2011-06-15 Impact factor: 10.612
Authors: Michael J Domanski; Kenneth Mahaffey; Vic Hasselblad; Sorin J Brener; Peter K Smith; Graham Hillis; Milo Engoren; John H Alexander; Jerrold H Levy; Bernard R Chaitman; Samuel Broderick; Michael J Mack; Karen S Pieper; Michael E Farkouh Journal: JAMA Date: 2011-02-09 Impact factor: 56.272
Authors: Stanton K Shernan; Jane C K Fitch; Nancy A Nussmeier; John C Chen; Scott A Rollins; Christopher F Mojcik; Kevin J Malloy; Thomas G Todaro; Thomas Filloon; Steven W Boyce; Deepak M Gangahar; Michael Goldberg; Lawrence J Saidman; Dennis T Mangano Journal: Ann Thorac Surg Date: 2004-03 Impact factor: 4.330
Authors: Carina Benstoem; Christian Stoppe; Oliver J Liakopoulos; Julia Ney; Dirk Hasenclever; Patrick Meybohm; Andreas Goetzenich Journal: Cochrane Database Syst Rev Date: 2017-05-05
Authors: Yabing Zhang; Xiyang Zhang; Dongmei Chi; Siyang Wang; Hua Wei; Hong Yu; Qian Li; Bin Liu Journal: Medicine (Baltimore) Date: 2016-09 Impact factor: 1.889
Authors: M Joannidis; W Druml; L G Forni; A B J Groeneveld; P M Honore; E Hoste; M Ostermann; H M Oudemans-van Straaten; M Schetz Journal: Intensive Care Med Date: 2017-06-02 Impact factor: 17.440